- Ascendis Pharma (Princeton, NJ)
- …combination products. + Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (eg, launch advisory comment ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs,… more
- Sumitomo Pharma (Trenton, NJ)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Bristol Myers Squibb (Madison, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and...compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with… more
- Taiho Oncology (Princeton, NJ)
- …of and experience interacting and negotiating with regulatory agencies, particularly the FDA . + Experience in biologics and/or antibody drug conjugate a plus ... all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug ...also within TOI. + Prepare strategy and plans for FDA /EMA meetings in coordination with TPC and TOI members.… more
- Pentax Medical (Montvale, NJ)
- …Sciences or a related field (Masters preferred) + Three-five years' experience in Regulatory Affairs for a FDA regulated employer + Thorough understanding of ... solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an...phone calls and meetings with the US Food and Drug Administration and Health Canada. + Participate in cross… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Sanofi Group (Morristown, NJ)
- …CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, ... **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown,...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more
- Stryker (Mahwah, NJ)
- **Senior Manager, Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager, Regulatory Affairs** , you will ... provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals for new product launches… more